Device and method for controlling nasal exudation

ABSTRACT

An inflatable device for insertion into a user&#39;s nose for controlling nasal exudation has an elongated shaft including at least one lumen for accommodating a fluid; an inflatable balloon connected to the shaft, the balloon being in fluid connection to the lumen; and an absorber for absorbing nasal exudates, the absorber being disposed at an outer circumference of the shaft and/or at a distal tip portion of the device. Another inflatable device for insertion into a user&#39;s nose for controlling nasal exudation has an elongated shaft including at least one lumen for accommodating a fluid; and an inflatable balloon connected to the shaft, the balloon being in fluid connection to the lumen; the balloon containing a cooling agent, wherein the cooling agent is configured to cool the balloon when coming into contact with the fluid.

BACKGROUND OF THE INVENTION

This invention relates generally to the controlling of nasal exudation,and more particularly to a device and method therefore.

Nasal exudation is a common phenomenon. One of the more common methodsof arresting such exudation is to insert an absorbing packing materialinto the nasal cavity. A large percentage in the order of 90% of allnose bleeds, which are a particularly unpleasant or even dangerous kindof nasal exudation, occur within the location of the vascular plexuswhich is located in the forward areas of the nasal cavity on the nasalseptum or nasal partition. The various networks of arteries, minuteblood vessels and capillaries in this area are the most common source ofnose bleeds or nasal hemorrhages.

There are various home remedies for simple nose bleeds such as coldcompresses to the neck, manually compressing the nostrils along withvarious other techniques, none of which are particularly effective sincethe actual site of the exudation (here, bleeding) is within the nasalcavity. Nose bleeds in this forward area of the vascular plexus commonlyreferred to as the Kiesselbach plexus, are relatively easy to control bya non-physician because of their ready accessibility and because theaffected area can be visually ascertained.

A pre-packaged nose bleed kit sold across the counter for home use, asknown from U.S. Pat. No. 5,383,891, includes a hemostatic tamponconstruction of a compressed synthetic hydrocellulose sponge materialwhich expands upon wetting, and a nasal bandage which provides anabsorbent drip pad under the nostrils as well as some means foranchoring a pull string of the tampon. This kit is still notsufficiently effective, and is not sufficiently readily applicable.

SUMMARY OF THE INVENTION

The present invention, according to its first aspect, is an inflatabledevice for insertion into a user's nose for controlling nasal exudation,the device comprising a shaft accommodating a fluid, and a balloonconnected or connectable to the shaft so as to be in fluid connectiontherewith. The balloon is inflatable by the fluid contained in theshaft, so as to exert pressure on the walls of the nasal cavity afterthe distal portion of the device has been inserted thereinto.

According to an embodiment, an absorber for absorbing nasal exudates isdisposed at an outer circumference of the shaft. This absorber maycomprise a section which remains visible after insertion. Further, theshaft may comprise at least one mark for indicating an amount of nasalexudates absorbed.

According to another embodiment, an absorber for absorbing nasalexudates is disposed at a distal tip portion of the device. In thiscase, the absorber may constitute the entire distal tip section apartfrom a support structure for the absorber. A length of the distalportion including the balloon and the tip-absorber may be limited to atmost 5 cm.

The above embodiments may be combined, such that there are absorbersections as well at the tip section as around the shaft. In embodimentswhere the balloon does not extend around the entire circumference, butonly partially or for the most part of the circumference, such as in acase where there are two distinct balloon sections, the two absorbersections may be contiguous. Additionally, some absorber material may bedisposed on the outer surface of the balloon itself.

According to another embodiment, the balloon contains a cooling agent.In this embodiment, the cooling agent may be configured to dissolve inthe liquid accommodated until use in the shaft's lumen. If an enthalpyof solution in the solvent is positive, cooling of the balloon willresult upon contact.

The device may comprise a valve, or a rupturable membrane, e.g. to keepthe solvent and the cooling agent separate until use. The shaft maycontain a plunger, with which the fluid or solvent can be urged into theballoon so as to inflate it, rupturing the membrane (if provided) orpassing through the valve (if provided) on its way. The embodimentcomprising the cooling agent may be combined with either or bothembodiments comprising the additional absorber outlined above.

According to another aspect, a method of controlling nasal exudationcomprises introducing an inflatable balloon into a (conscious) user'snose, inflating the balloon, and internally cooling the balloon so as toreduce nasal exudation. By “internally” it is meant that the cooling isnot achieved by e.g. flowing a pre-cooled fluid through the device; norby applying pre-cooled packaging to the outside of the nose. The coolingmay be achieved by dissolving a suitable agent in a solvent wherein theagent has a positive enthalpy of solution. The solvent, beforecontacting the cooling agent, may be urged through a constriction like avalve or a rupturable membrane.

According to yet another aspect, a cooling agent having a positiveenthalpy of solution in a solvent is used in the manufacturing of adevice for controlling nasal exudation. Both the solvent and the solute(agent) are arranged in the device, such that in operation, the agentdissolves in the solvent, thereby cooling the device and accordingly thenose.

While in the above description, it has been assumed that the devicecomprises an inflatable balloon connected to a shaft, these componentsmay likewise be provided as separate items. It is, e.g., possible toprovide only the balloon, along with any optional absorber sections,which balloon for use may be connected to a fluid-filled syringe. Inthis case, the syringe provides the shaft and lumen required to inflatethe balloon.

It is further conceivable to arrange a cooling agent initially outsidethe inflatable part of the balloon in such a manner that the agent, inuse, first comes into contact with the fluid, e.g. water, dissolvestherein, and only then is urged into the inflatable part of the balloonso as to inflate it. For the purpose of this description, such structurewill be considered part of the invention insofar as before use, theagent and the fluid are kept separate, and in use, the cooling solutionis contained in the inflated balloon.

Further advantages of the invention will become apparent from thefollowing description and the accompanying drawings. These shall not beconstrued as limiting, the invention being solely defined by theappended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a cross sectional view of the inventive device;

FIG. 2 shows an initial phase of the inventive method; and

FIG. 3 shows a later phase of the inventive method.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

In the embodiment according to FIG. 1, the device comprises a bodyportion 7 having a cylindrical outer wall 11, a likewise cylindricalinner wall 13, accommodating water as the fluid 15 in its section below(proximal to) the septum 17, and an absorber 19 arranged in part betweenthe outer 11 and inner 13 walls, and for another part around thatsection of the body 7 housing the septum 17. A part of the outer wall 11is transparent, and bears marks forming a scale 21, for indicatingprogress of nasal exudates being absorbed by the absorber. For thispurpose, the absorber 19 may contain an indicator agent if the nasalexudates are colorless (not necessary for blood).

A plunger 23, actuated via a plunger rod 25, defines a lumen of theshaft, wherein the plunger may be moved in the lengthwise directionindicated by the double-tipped arrow; namely, inwardly (upward inFIG. 1) when activating the device, and outwardly (downward in FIG. 1)before removing the device from the nose after use.

In the embodiment shown, the device's body 7 is contiguous with aballoon section 5 arranged distally of the body 7, which balloon sectioncomprises the inflatable balloon 26. On the right hand side of FIG. 1,the balloon is shown in its normal, non-inflated state 26′; whereas onthe left-hand side of FIG. 1, the balloon is shown in its inflated state26″. The balloon section 5 further comprises a chamber having a chamberwall 27 inside the balloon 26. The chamber wall 27 has openings 28formed therein, for allowing an inflating fluid to pass therethrough,and ultimately to exert a pressure on the balloon 26 from the insidethereof. Inside the chamber, an agent 29 such as potassium nitrate(KNO.sub.3) or the like is accommodated, which agent will readilydissolve in water (or other suitable fluid) under cooling when broughtinto contact. The agent may be provided in a small bag 30 made of afluid permeable or perforated material, or a material disintegratingwhen brought into contact with the fluid. It is envisaged that thematerial of the bag will present some resistance to the ingress ofwater, so that the dissolving of the cooling agent will take some time,e.g. between 2 and 20 minutes, or between 5 and 10 minutes, in orderthat the cooling will proceed in a smooth manner, avoiding undesirablefreezing of the water.

Usually, around 2 ml will be sufficient to inflate the balloon 26. Forchildren, less than that may be required; accordingly, a suitable volumeof the lumen will generally be between 1 ml and 5 ml.

Although not shown, a connector arrangement may be provided at thedistal end of the shaft, in order to assemble the body to the balloonsection 5 described above. In this case, the septum 17 may comprise twosepta in succession, wherein one septum forms part of the body section 7(or syringe) and the other septum forms part of the balloon section 5,for sealing the balloon 26 until use. The connector assembly may consistof a male thread on the shaft part, and a matching female thread on theballoon part, or vice versa. It is envisaged to provide the variousparts of the device, at least the shaft part including the plunger andthe balloon part, as separate entities, which are assembled onlyimmediately before use. The fluid may be provided in the shaft/plungerpart, such as a syringe, or may be (tap or distilled) water to be filledinto the lumen directly before use. In this variant, the plunger isinitially in a position pushed inside the shaft, is drawn out of theshaft with the tip of the syringe held into a reservoir containing water(or into water flowing from a tap or the like) so as to suck water intothe lumen of the syringe, and is then connected to the balloon part,ready for use. In another variant, it is envisaged to provide even thecooling agent separately. In this embodiment, the cooling agent may beconfigured to exert its cooling action upon being mechanicallyactivated, such as pressed or bent. Such pressing or bending may triggera transition from a metastable state into a stable state, the transitionproceeding under cooling. The activated cooling agent is then introducedinto the balloon part, the shaft part connected thereto, the deviceinserted into the nostril and the balloon inflated. In this embodiment,it is not necessary that the process of dissolution proceeds undercooling, nor that the cooling agent dissolves in the fluid in the firstplace; rather, the fluid may merely serve as a heat conductor (from thenasal cavity wall into the balloon).

At the distal side of the chamber, a support arrangement such as two (ormore) hooks 31 for holding a further absorber 33 is located. The supportarrangement 31 and the absorber 33 form a tip section 9 of the device.The shape of the absorber 33 in this example is frustoconical or conicalor egg-like, in order to facilitate insertion of the tip section 9 intothe nostril.

In operation, depicted in FIGS. 2 and 3, the device is farther insertedinto the nostril, such that the balloon section 5 is likewise inside thenostril, but the scale 21 is outside thereof and still visible. At thisstage, the balloon 26′ is not yet inflated (FIG. 2). It may be seen thatthe length L of the device's balloon section 5 and tip section 9combined is limited so as not to abut against the upper wall of thenasal cavity. In this embodiment, the length L is about 4 cm; generally,it will usually be in the range 3-5 cm.

After insertion, the plunger 23 is displaced inwardly so as to urge thefluid 15 contained in the lumen through the septum 17 and into thechamber (which in this embodiment accommodates the cooling agent 29).The fluid further exits the chamber through the openings 28 and therebyinflates the balloon 26″, as shown in FIG. 3. The balloon in this mannerexerts some gentle pressure on the inside of the nasal wall, helping tocontrol nasal exudation. At the same time, the balloon seals the nostrilto prevent further exudation. Any exudates oozing out around the balloon26 will be absorbed by the absorber 19 arranged around the body 7;additionally, the absorber 33 constituting the tip section 9 will absorbany exudates otherwise accumulating inside of the nasal cavity.Naturally, if the device is to be used to stop nose bleed, it isconceivable to provide a vasoconstricting agent in the absorbersections.

As long as the exudation continues, the front line of the exudateabsorbed by the proximally arranged absorber 19 will move along thelength of the scale 21 on the shaft, as indicated in FIG. 3. Thestalling of this progress would thus indicate ceasing of exudation. Tothe end of more easily monitoring the progress of the exudates, parts ofthe shaft may be made of a transparent, preferably polymeric, material.The scale may be formed as a series of equidistant protrusions or markson the otherwise uniform outer surface of the shaft. A transparentlengthwise strip is sufficient for this purpose, whereas the remainderof the outer surface may be opaque.

In order for the cooling agent 29 to perform its function, it shouldhave a positive enthalpy of solution in the fluid 15. I.e., under normalconditions and constant pressure, the dissolving shall readily takeplace, but shall require input of energy into the solution. The requiredenergy will be provided by the thermal energy of the solvent and solute.The process will thus lead to internal cooling of the solution andtherefore of the balloon 26 as a whole. Via the thin envelope of theballoon 26, the inside of the nasal cavity will likewise be cooled, andexudation will be slowed or stopped. Similarly, any swelling of the nosewill be reduced.

It may be estimated that an enthalpy of dissolution of more than 10kJ/mol may be required to achieve sufficient cooling. Herein, it isassumed that an amount of between 0.1 g and 1 g of the cooling agent 29may be suitably accommodated in the chamber.

While the invention has been described above in the context of specificembodiments, the skilled person will become aware of various suitablemodifications and variations. The above description accordingly shallnot be construed as limiting for the invention, which is defined by theappended claims only.

The invention claimed is:
 1. A method of controlling bleeding from auser's bodily cavity using a cooling agent, the method comprising:introducing an inflatable balloon into the user's bodily cavity;inflating the balloon with a fluid comprising the cooling agent; andinternally cooling the balloon with the cooling agent so as to reducethe bleeding from the bodily cavity, wherein the internally coolingcomprises dissolving the cooling agent in a solvent so as to form asolution, said solution constituting the fluid.
 2. The method accordingto claim 1, wherein the solvent is urged through a valve or a rupturablemembrane before the solvent comes into contact with the cooling agent todissolve the cooling agent.
 3. The method according to claim 1,comprising a solid having a positive enthalpy of solution in thesolvent.
 4. A method of controlling bleeding from a user's bodilycavity, comprising: introducing a single inflatable balloon into theuser's bodily cavity; inflating the balloon with a liquid; andinternally cooling the balloon with a cooling agent internally coolingthe liquid so as to reduce bleeding from the user's bodily cavity,wherein the internally cooling comprises dissolving the cooling agent inthe liquid.
 5. A method of controlling bleeding from a user's bodilycavity, comprising: introducing a single inflatable balloon into theuser's bodily cavity; inflating the balloon with a liquid; andinternally cooling the balloon with a cooling agent internally coolingthe liquid so as to reduce bleeding from the user's bodily cavity,wherein the liquid is urged through a valve or rupturable membranebefore the liquid comes into contact with the cooling agent to dissolvethe cooling agent.
 6. A method of controlling bleeding from a user'sbodily cavity, comprising: introducing a single inflatable balloon intothe user's bodily cavity without introducing the balloon farther thannecessary for controlling the bleeding, and positioning the balloon inthe user's bodily cavity; inflating the balloon with a liquid; andinternally cooling the balloon with a cooling agent internally coolingthe liquid so as to reduce bleeding from the bodily cavity, wherein thebodily cavity comprises a nasal cavity and wherein the inserting of thesingle inflatable balloon into the user's bodily cavity withoutintroducing the balloon farther than necessary for controlling thebleeding comprises inserting the single inflatable balloon not furtherthan the user's vascular plexus.